ANALGESIC- menthol spray 
Ouwee Jones, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

OuWee Jones PAIN RELIEF SPRAY

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses

Temporary relief of jellyfish stings.

Warnings

For external use only

Flammable. Keep away from flame.

Keep out of reach of children. If swallowed get medical help or contact a poison center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

Questions or Comments
855-37-OUWEE or
www.ouweejones.com

Distributed By:
OuWee Jones Co.
PO Box 118, Mobile, AL 36601
www.ouweejones.com

PRINCIPAL DISPLAY PANEL

NDC 76417-8200-1

Ou! Wee!

Jellyfish Sting Relief

#1 Recommended Jellyfish Pain Relief Spray

4 fl. oz. (118 ml)

PRINCIPAL DISPLAY PANEL
ANALGESIC 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76417-8200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol700 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
isopropyl alcohol (UNII: ND2M416302)  
glycerin (UNII: PDC6A3C0OX)  
eucalyptus oil (UNII: 2R04ONI662)  
methyl salicylate (UNII: LAV5U5022Y)  
peppermint oil (UNII: AV092KU4JH)  
coconut oil (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76417-8200-10.118 L in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/26/2011
Labeler - Ouwee Jones, LLC (969347462)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE

Revised: 10/2011
Document Id: ba834958-0a80-4778-9383-e3dfc259a2eb
Set id: 09daa7a9-72f6-40c7-90f3-4c4f0852e99f
Version: 1
Effective Time: 20111026
 
Ouwee Jones, LLC